Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Not Applicable

• Conditions: Prosthesis Durability
• Interventions: Device: Maxillary implant overdenture

• Registration Number: NCT06050213
• Lead Sponsor: Mansoura University

Brief Summary

This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-08
• Status Verified: 2023-09
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-12-26
• Study Completion: 2024-07-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.

  • Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
  • The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
  • Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
  • Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.

Exclusion Criteria

• o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.

  • History of irradiation in head-and-neck area.
  • Heavy smokers (more than 10 cigarettes per day)
  • Parafunctional habits such as bruxism.
  • Psychiatric disorders or unrealistic expectations.
  • Positive pregnancy test up to 5 days before surgery.
  • Severe thrombocytopenia and bleeding disorders.
  • Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
  • Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
  • Patients with TMJ disorders or poor neuromuscular coordination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
three implant group	Maxillary implant overdenture	Maxillary overdenture retained by 3 unsplinted implants in midline and canines regions.
five implant group	Maxillary implant overdenture	Maxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions.
four implant group	Maxillary implant overdenture	Maxillary overdenture retained by 4 unsplinted implants in canines and molar regions.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	one year	patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Bite force	one year	Bite force will be evaluated for all patients by a digital bite force device

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt